NDC 36800-636

Topcare Esomeprazole Magnesium

Esomeprazole

Topcare Esomeprazole Magnesium is a Oral Capsule, Delayed Release in the Human Otc Drug category. It is labeled and distributed by Topco Associates Llc. The primary component is Esomeprazole.

Product ID36800-636_429dfe02-50b7-414a-98af-cc3c9b0afddb
NDC36800-636
Product TypeHuman Otc Drug
Proprietary NameTopcare Esomeprazole Magnesium
Generic NameEsomeprazole
Dosage FormCapsule, Delayed Release
Route of AdministrationORAL
Marketing Start Date2017-09-22
Marketing CategoryANDA / ANDA
Application NumberANDA207193
Labeler NameTopco Associates LLC
Substance NameESOMEPRAZOLE
Active Ingredient Strength20 mg/1
Pharm ClassesCytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 36800-636-01

1 BOTTLE in 1 CARTON (36800-636-01) > 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE
Marketing Start Date2017-09-22
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 36800-636-02 [36800063602]

Topcare Esomeprazole Magnesium CAPSULE, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA207193
Product TypeHUMAN OTC DRUG
Marketing Start Date2017-09-22

NDC 36800-636-01 [36800063601]

Topcare Esomeprazole Magnesium CAPSULE, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA207193
Product TypeHUMAN OTC DRUG
Marketing Start Date2017-09-22

NDC 36800-636-03 [36800063603]

Topcare Esomeprazole Magnesium CAPSULE, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA207193
Product TypeHUMAN OTC DRUG
Marketing Start Date2017-09-22

Drug Details

Active Ingredients

IngredientStrength
ESOMEPRAZOLE20 mg/1

OpenFDA Data

SPL SET ID:32918b45-ff9a-45bd-8d90-e008bf4d8458
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 606726
    • UPC Code
  • 0036800232976

    • NDC Crossover Matching brand name "Topcare Esomeprazole Magnesium" or generic name "Esomeprazole"

    NDCBrand NameGeneric Name
    36800-627topcare esomeprazole magnesiumesomeprazole magnesium
    36800-636Topcare Esomeprazole MagnesiumEsomeprazole
    0113-0732basic care esomeprazole magnesiumEsomeprazole
    41163-539equaline esomeprazole magnesiumEsomeprazole
    0591-4187EsomeprazoleEsomeprazole
    30142-989esomeprazoleesomeprazole
    0363-1699Esomeprazole Magnesiumesomeprazole
    0363-1898esomeprazole magnesiumEsomeprazole
    11822-0024esomeprazole magnesiumesomeprazole
    11822-0898esomeprazole magnesiumEsomeprazole
    30142-273esomeprazole magnesiumesomeprazole
    30142-413esomeprazole magnesiumEsomeprazole
    37012-898esomeprazole magnesiumEsomeprazole
    37808-719Esomeprazole Magnesiumesomeprazole
    37808-898esomeprazole magnesiumEsomeprazole
    0113-0651good sense esomeprazole magnesiumesomeprazole
    0113-0898Good Sense Esomeprazole MagnesiumEsomeprazole
    0536-1131rugby esomeprazole magnesiumEsomeprazole
    21130-088signature care esomeprazole magnesiumEsomeprazole
    21130-714signature care esomeprazole magnesiumesomeprazole
    11673-898up and up esomeprazole magnesiumEsomeprazole
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